Test Items

Company Specification

EP

USP

Characters

White or almost white powder, highly hygroscopic

Identification

Thrombotest: Conforms

Chromatographic identity: Conforms

1H NMR Spectrum: Conforms

1H NMR Spectrum: Conforms

Liquid Chromatography: Conforms

Weight-average molecular weight: 15000~19000

Sodium: Conforms

Sodium: Conforms

Anti-factor Xa to anti-factor IIa ratio:0.9~1.1

Anti-factor Xa to anti-factor IIa ratio:0.9~1.1

Tests

Clarity and color

Clarity: Clear, Color: by 5 or better

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Nitrogen

1.5～2.5%（dry substance）

1.3～2.5%（dry substance）

Nucleotidic impurities

A260 ≤ 0.15(4mg/ml)

≤ 0.1（w/w）

Related substances

Conforms

————

Limit ofgalactosamine in total hexosamine

————

≤ 1.0%

Oversulfated chondroitin sulfate

————

Conforms

pH

5.5～8.0（1%）

5.5～7.5（1%）

Loss on drying

≤ 8.0%（60℃ Dry in Vacuum, 3h）

≤ 5.0%（60℃ Dry in Vacuum, 3h）

Residue on ignition

————

28.0%～41.0%

Bacterial endotoxin

≤ 0.01 IU/International Unit of Heparin

≤ 0.03 USP U/International Unit of Heparin

Heavy metal

≤ 30ppm

≤ 30ppm

Sodium

10.5～13.5%（dry substance）

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Proteins

≤ 0.5%（dry substance）

≤ 0.1%（Weight ratio）

Activity

≥ 180 IU/mg（dry substance）

≥ 180 USP U/mg（dry substance）

Microbial Impurities

TAMC

≤ 1000cfu/g

≤ 1000cfu/g

TYMC

≤ 100cfu/g

≤ 100cfu/g

E.coli

Conforms

Conforms

Staphylococcus aureus

Conforms

Conforms

Salmonella

Conforms

Conforms